Rexton

FDA UDI

Class II (US FDA UDI)

by WS Audiology USA, Inc.

Identity

Trade Name: Rexton FDA UDI
Generic Name: Air-conduction hearing aid, behind-the-ear FDA UDI
Device Name: Rexton HA EMERALD XS 30 E1 SLV Hearing Aid FDA UDI
Model / Reference: HA EMERALD XS 30 E1 SLV FDA UDI
Description: Rexton HA EMERALD XS 30 E1 SLV Hearing Aid FDA UDI

Identifiers

Catalog Number: 10949082 FDA UDI
Primary DI / UDI-DI: 04056839048832 FDA UDI
FDA Product Code: OSM FDA UDI
GMDN Term: Air-conduction hearing aid, behind-the-ear FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 874.3305 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Air-conduction hearing aid, behind-the-ear

Rexton by WS Audiology USA, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Air-conduction hearing aid, behind-the-ear.

Oticon — Oticon A/S · Class II
Amplifon — Sonova AG · Class II
Phonak Naída L30-SP — Sonova AG · Class II
Phonak — Phonak, Inc. · Class II
GN ReSound — Gn Hearing A/S · Class II
NUEAR — Starkey Laboratories Inc. · Class II
HHM — Oticon A/S · Class II
Hansaton — Hansaton Akustik GmbH · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: WS Audiology USA, Inc.

Sources (1)

FDA UDI 3501ee1d-65d9-4b77-a548-630d0b9006ba 35 fields · synced May 31, 2026